Warning To Hearing Aid Dispensers (To Comply With The U.s. Food And Drug Administration (Fda) Regulations) - Unitron Moxi User Manual

Warning to hearing aid dispensers
(to comply with the U.S. Food and Drug Administration
(FDA) regulations)
A hearing aid dispenser should advise a prospective hearing aid
user to consult promptly with a licensed physician (preferably an
ear specialist) before dispensing a hearing aid if the hearing aid
dispenser determines through inquiry, actual observation, or
review of any other available information concerning the
prospective user, that the prospective user has any of the
following conditions: (i) Visible congenital or traumatic deformity
of the ear. (ii) History of active drainage from the ear within the
previous 90 days. (iii) History of sudden or rapidly progressive
hearing loss within the previous 90 days. (iv) Acute or chronic
dizziness. (v) Unilateral hearing loss of sudden or recent onset
within the previous 90 days. (vi) Audiometric air-bone gap equal
to or greater than 15 decibels at 500 hertz (Hz), 1,000 Hz, and
2,000 Hz. (vii) Visible evidence of significant cerumen
accumulation or a foreign body in the ear canal. (viii) Pain or
discomfort in the ear. Special care should be exercised in
selecting and fitting a hearing aid whose maximum sound
pressure level exceeds 132 decibels because there may be risk of
impairing the remaining hearing of the hearing aid user. [This
provision is required only for those hearing aids with a maximum
sound pressure capability greater than 132 decibels (dB).]
Important notice for prospective hearing aid users
Good health practice requires that a person with a hearing loss
have a medical evaluation by a licensed physician (preferably a
physician who specializes in diseases of the ear) before
purchasing a hearing aid.
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Licensed physicians who specialize in diseases of the ear are
often referred to as otolaryngologists, otologists or
otorhinolaryngologists. The purpose of medical evaluation is to
assure that all medically treatable conditions that may affect
hearing are identified and treated before the hearing aid is
purchased. Following the medical evaluation, the physician will
give you a written statement that states that your hearing loss
has been medically evaluated and that you may be considered a
candidate for a hearing aid. The physician will refer you to an
audiologist or a hearing aid dispenser, as appropriate, for a
hearing aid evaluation. The audiologist or hearing aid dispenser
will conduct a hearing aid evaluation to assess your ability to
hear with and without a hearing aid. The hearing aid evaluation
will enable the audiologist or dispenser to select and fit a hearing
aid to your individual needs. If you have reservations about your
ability to adapt to amplification, you should inquire about the
availability of a trial-rental or purchase-option program. Many
hearing aid dispensers now offer programs that permit you to
wear a hearing aid for a period of time for a nominal fee after
which you may decide if you want to purchase the hearing aid.
Federal law restricts the sale of hearing aids to those individuals
who have obtained a medical evaluation from a licensed
physician. Federal law permits a fully informed adult to sign a
waiver statement declining the medical evaluation for religious or
personal beliefs that preclude consultation with a physician. The
exercise of such a waiver is not in your best health interest and
its use is strongly discouraged.
Children with hearing loss
In addition to seeing a physician for a medical evaluation, a child
with a hearing loss should be directed to an audiologist for
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